Sacral Neuromodulation for Chronic Pelvic Pain

(SNM_CPP Trial)

Recruiting at 1 trial location

Overseen By Jennifer Giordano, BSN

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: William Beaumont Hospitals

Disqualifiers: Pelvic cancer, Severe diabetes, Interstitial cystitis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 12 months

25 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores sacral neuromodulation (SNM) to determine its effectiveness in helping women with chronic pelvic pain (CPP). SNM involves a minimally invasive procedure where a small device is implanted to manage pain signals in the pelvic area. Women who have experienced severe pelvic pain for at least six months and have not found relief with other treatments might be suitable candidates for this trial. The trial aims to assess whether SNM can effectively reduce pain and improve quality of life for those affected. As an unphased trial, it offers participants the chance to contribute to pioneering research that could lead to new treatment options for chronic pelvic pain.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you must not change your medication regimen for pelvic pain for more than 4 weeks before screening. You also cannot start any new treatments for chronic pelvic pain before a certain point in the study.

What prior data suggests that sacral neuromodulation is safe for treating chronic pelvic pain?

Research shows that sacral neuromodulation (SNM) is generally safe. The FDA has approved it for urinary and fecal incontinence, confirming its safety for these conditions.

Studies have found that SNM can also help with chronic pelvic pain (CPP). Specifically, one study found that SNM significantly reduces pain and improves the quality of life for people with CPP. While these studies mainly assess the treatment's effectiveness, they also suggest it is well-tolerated.

Since SNM is already used for other medical conditions, there is some confidence in its safety for CPP. However, ongoing monitoring for specific side effects or issues when using it for different conditions remains important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the usual treatments for chronic pelvic pain, which often involve medications or physical therapy, Sacral Neuromodulation (SNM) offers a unique approach by directly targeting the nerves. This treatment involves using an implantable device to send electrical impulses to the sacral nerves, which can help modulate pain signals and improve symptoms. Researchers are excited about SNM because it provides a more targeted option, potentially offering relief for patients who haven't responded well to other treatments. Additionally, the ability to adjust the device settings offers personalized treatment, which can be fine-tuned to each patient's needs.

What evidence suggests that sacral neuromodulation is effective for chronic pelvic pain?

Research shows that sacral neuromodulation (SNM), which participants in this trial will receive, can effectively treat chronic pelvic pain. Studies have found that it greatly reduces pain and improves patients' quality of life. Evidence suggests that SNM offers both quick and lasting relief. Although the FDA has approved SNM for treating urinary and fecal incontinence, this trial tests its potential to alleviate chronic pelvic pain. This treatment involves implanting a small device in the body to help control nerve signals related to pain. ^{1 2 4 5 6}

Who Is on the Research Team?

Kenneth M Peters, MD

Principal Investigator

Corewell Health William Beaumont University Hospital

Are You a Good Fit for This Trial?

Women aged 22-70 with chronic pelvic pain who've tried at least one treatment without success can join. They mustn't change their pain meds for 4 weeks before the trial, use effective birth control, and commit to the study's duration. Exclusions include pelvic cancer history, severe medical conditions that could affect results, certain concurrent pain treatments, psychiatric disorders as judged by the physician (except stable depression or anxiety), frequent UTIs, uncontrolled diabetes with nerve issues, prior SNM device or trial participation, allergies to specific materials in the device components (titanium etc.), spinal cord stimulators/drug pumps implanted regardless of status (on/off), breastfeeding or pregnant women not using contraception properly.

Inclusion Criteria

I have tried at least one non-surgical treatment without success.

I am willing and able to follow all study rules and attend all appointments.

Provision of signed and dated informed consent form

Exclusion Criteria

My diabetes is severe or uncontrolled, or affects my nerves.

Subject with documented history of allergy to titanium, zirconia, polyurethane, epoxy, or silicone

I am currently being treated for cancer, not including skin cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Device Implantation

Sacral neuromodulation device is implanted and initial settings are adjusted

1 day

1 visit (in-person, operating room)

Post-Operative Adjustment

Device settings are adjusted and participants complete study questionnaires

2 weeks

1 visit (in-person)

Treatment

Participants receive ongoing sacral neuromodulation with device settings adjusted as needed

12 months

Multiple visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Sacral Neuromodulation

Trial Overview The trial is testing sacral neuromodulation—a minimally invasive procedure where a small device is implanted—to see if it helps women suffering from chronic pelvic pain. The effectiveness will be measured throughout the study period after a single implantation procedure.

How Is the Trial Designed?

Group I: SNM for the treatment of CPP Experimental Treatment 1 Intervention

Patients will be enrolled based on study eligibility criteria. Eligible patients will be scheduled for a Interstim X implant in the operating room. The procedure is completed under anesthesia, either conscious sedation with intubation or breathing assistance. Under fluoroscopic guidance a standard lead will be introduced. Each electrode on the lead will be tested by confirming motor response on at least 3 of 4 leads. Next the implantable pulse generator will be placed in a subcutaneous pocket and secured. Impedance will be tested, 4 standard programs will be set, and then the device will be shut off. The device settings will be adjusted per protocol and the device will be turned on and off during visits 2-7.

Sacral Neuromodulation is already approved in United States, European Union, Canada for the following indications:

Approved in United States as InterStim for:

• Overactive bladder
• Urinary urgency
• Frequency
• Urge incontinence
• Nonobstructive urinary retention
• Chronic fecal incontinence

Approved in European Union as InterStim for:

• Overactive bladder
• Urinary urgency
• Frequency
• Urge incontinence
• Nonobstructive urinary retention
• Chronic fecal incontinence
• Chronic constipation

Approved in Canada as InterStim for:

• Overactive bladder
• Urinary urgency
• Frequency
• Urge incontinence
• Nonobstructive urinary retention
• Chronic fecal incontinence
• Chronic constipation

Who Is Running the Clinical Trial?

William Beaumont Hospitals

Lead Sponsor

Trials

153

Recruited

113,000+

Published Research Related to This Trial

The median lifespan of the InterStim™ and InterStim™ II devices used for sacral nerve neuromodulation is 7.29 years and 5.9 years, respectively, indicating that the newer model has a shorter lifespan than the original.

The shorter lifespan of the InterStim™ II is linked to increased long-term hospital costs, suggesting that while both devices are effective for managing incontinence, the choice of device may impact overall treatment expenses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Retrospective study of sacral neuromodulator implantations in a French hospital center: Lifespan and hospital costs assessment. Daikh, A., Reymond, F., Lombardo, D., et al.[2023]

Sacral neuromodulation (SNM) with the InterStim II system has evolved into a minimally invasive procedure, significantly improving treatment success rates for chronic urinary and bowel dysfunction, with a response rate of approximately 80%.

Recent advancements, such as the tined lead and smaller neurostimulator, have enhanced patient comfort, reduced technical failures, and improved quality of life, making SNM a viable option for patients who do not respond to conservative treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Latest technologic and surgical developments in using InterStim Therapy for sacral neuromodulation: impact on treatment success and safety. Spinelli, M., Sievert, KD.[2008]

A review of over 44,000 adverse event reports related to sacral neuromodulation (SNM) devices found that many reported complications (43.2%) were not true adverse events but rather issues related to device use and the need for better technical support.

The low number of lawsuits (only four identified) over 24 years suggests that SNM devices have a strong safety profile, with complications often stemming from inappropriate patient selection or lack of follow-up rather than device malfunction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Understanding a decade of safety reporting for sacral neuromodulation in the Food and Drug Administration Manufacturer and User Facility Device Experience database. Carlton, CE., Souders, CP., Chertack, NA., et al.[2023]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36877182/

Sacral neuromodulation in the management of chronic ... Sacral Neuromodulation is a reasonably effective treatment of Chronic Pelvic Pain and significantly reduces pain and increases patients' quality of life.

2. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/nau.25167

Sacral neuromodulation in the management of chronic ... Sacral Neuromodulation is a reasonably effective treatment of Chronic Pelvic Pain and significantly reduces pain and increases patients' quality of life

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3511936/

Efficacy of sacral neuromodulation in treating chronic pain ... The objective of this review is to evaluate the efficacy and safety of sacral neuromodulation in treating chronic pelvic pain related to Painful bladder ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06150599

Sacral Neuromodulation for Chronic Pelvic Pain In this study we are assessing the effectiveness of sacral neuromodulation in women with suffering from chronic pelvic pain (CPP), through a single device ...

5. bmcwomenshealth.biomedcentral.com bmcwomenshealth.biomedcentral.com/articles/10.1186/s12905-025-03699-y

Good long-term results of sacral neuromodulation for ... SNM could be an effective treatment of chronic pelvic pain (CPP), significantly reducing pain and increasing patients' quality of life with immediate to long- ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S2772973724006271

The future of neuromodulation for functional pelvic problems Neuromodulation is an effective and up-to-date technique in the treatment of a variety of functional pelvic disorders in both genders.